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ag2479 posted a new topic "Protocol Deviations vs. Violations in Clinical Trials" – 4 days, 12 hours ago
One of the complex areas in clinical trial management is handling protocol noncompliance – understanding the line between a deviation and a violation. While violations can jeopardize the entire study, deviations are often viewed as minor and manageable. But in… Read more»
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ag2479 posted a new topic "Role of Communication Plans in Clinical Trial Execution" – 4 days, 12 hours ago
One element that could be sometimes undervalued in clinical trial management is the Communication Plan. During the Executing phase, consistent and strategic communication with site coordinators can make or break enrollment and data quality. Yet in practice, communication is often… Read more»
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ag2479 posted a new topic "Balancing Cost, Time, and Quality in Clinical Trials" – 4 days, 13 hours ago
The project management triangle (Cheap, Fast, Good: Pick Two) takes on a level of complexity in the context of clinical trials. Regulatory compliance, patient safety, and scientific rigor limit the ability to cut corners, making it nearly impossible to sacrifice… Read more»
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ms3548 replied to the topic "Employee Engagement" – 4 days, 14 hours ago
Employee engagement is indeed crucial for productivity and retention. One effective strategy I’ve seen is the implementation of personalized development plans. These plans align individual career goals with organizational objectives, providing employees with a clear path for growth and development…. Read more»
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ms3548 replied to the topic "What factors should be considered during selection a vendor?" – 4 days, 14 hours ago
In addition to cost and quality, several other factors should be considered when selecting a vendor. Production scalability is crucial to ensure the vendor can meet increasing demand without compromising quality. Environmental impact is another important consideration, as sustainable practices… Read more»
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ms3548 replied to the topic "Creating Realistic Schedules in Clinical Trials" – 4 days, 14 hours ago
In addition to IRB approval delays and patient-related setbacks, clinical trials often face challenges such as patient recruitment and retention issues, protocol deviations, and regulatory hurdles. Patient recruitment can be particularly difficult due to strict eligibility criteria and lack of… Read more»
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kelsipetrillo replied to the topic "Employee Engagement" – 4 days, 15 hours ago
I agree with the previous response that regular evaluations are helpful for improving employee engagement. One topic that I see being heavily discussed often on professional platforms such as LinkedIn is the ability of companies to treat their employees as… Read more»
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kelsipetrillo posted a new topic "Creating Realistic Schedules in Clinical Trials" – 4 days, 16 hours ago
A critical component of clinical trial planning is to create a detailed timeline, which can be enhanced with tools such as Gantt charts. However, clinical trials can pose a unique set of challenges compared to other types of projects because… Read more»
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kelsipetrillo replied to the topic "Why Do People Leave?" – 4 days, 16 hours ago
As has been discussed throughout this thread, there are a variety of factors that influence retention. When considering how authority affects whether employees want to stay or leave, it is necessary to understand the authoritative model used at the company…. Read more»
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mrm62 replied to the topic "Vendor Decision" – 5 days, 1 hour ago
I decided to go with multiple vendors as decreasing the project risk is always a good practice, as well as the fact that the project as described was not time sensitive. In addition, there is always the fact that one… Read more»
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os97 replied to the topic "Time Management in Medical Devices" – 5 days, 1 hour ago
Tackling the aspect of keeping up with fast-evolving technology in terms of biomedical device development, the best way to do so is via proactive action. Rather than keeping up with change, it is best to try and predict what changes… Read more»
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pz98 replied to the topic "Scope Management in Biomedical Devices" – 5 days, 1 hour ago
Adding on to the others, COVID is a prime example of where agile scope management was applied. As more information came out, project scopes most likely increased. One example of this is a company called Inovio. They were developing a… Read more»
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os97 replied to the topic "Vendor Decision" – 5 days, 1 hour ago
Considering the mini-sim from this week, going for multiple vendors can be more beneficial for next steps in terms of finalizing alternate sources for the coating material. In considering vendors available for a product, fitting the requirements stated within the… Read more»
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pz98 replied to the topic "Scope Management and the Role of the WBS in Project Clarity" – 5 days, 1 hour ago
WBS should be closely aligned with a company’s risk management planning. Different deliverables like the change history are effective in a WBS, but incorporating a risk-perspective into the WBS as well can make areas with more uncertainty more visible to… Read more»
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mrm62 replied to the topic "Changining staff" – 5 days, 2 hours ago
The first step would have to be to have someone fill in those time sensitive roles. This can include moving people familiar with the process into the vacant role and the hiring of new talent. Time and resources would then… Read more»
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os97 replied to the topic "Human Resource Management" – 5 days, 2 hours ago
To touch upon the mention of scenario-based simulation training, within the company I am currently working in, we are mandated to complete certain virtual training sessions each quarter, keeping us up to date with new technologies brought to the company,… Read more»
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mrm62 replied to the topic "Scope, Time, and Cost control" – 5 days, 2 hours ago
There are times where changing the scope may be the only step feasible due to factors that couldn’t be controlled. This can include expansion or shrinking of the focus of a project to fit what can only be currently done… Read more»
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BenjaminRofail replied to the topic "Human resource management" – 5 days, 2 hours ago
It is difficult to state that only one person can do a certain job. One person can certainly have more experience and knowledge, but is not the only one capable. This person going on maternity leave can hold training sessions… Read more»
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pmd5 replied to the topic "Familiarity of eachothers work" – 5 days, 2 hours ago
Absolutely, I believe in a project environment, it is essential to be informed of what each and every team member is doing and what they should be doing to allow smooth cooperation and progress. When the team members are aware… Read more»
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pmd5 replied to the topic "Changining staff" – 5 days, 2 hours ago
If a member leaves midway through a project, the first step is to reassess and briefly redistribute their responsibilities to capable colleagues. Also, to prevent disruptions, I would have the exiting person thoroughly document their procedures and, if possible, be involved in a brief transition. Meanwhile, holding a short team meeting to r…[Read more]
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